FDA.reportPublic FDA data

WasherCap™ Inserter 9mm & 10mm

Primary DI
08437019739508
Brand
WasherCap™ Inserter 9mm & 10mm
Company
ABANZA TECNOMED SL.
Model
21
Device description
Instrument used to place the cap of the WasherCap™ Fixation System at the entrance of the tunnel.
Published
2023-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28437019739502PackageGS11In Commercial Distribution
08437019739508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2843701973950228437019739502
08437019739508084370197395088437019739508

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(866) 550-7070customerservice@abanzamed.com

Regulatory Flags#

DUNS number
465714287
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437019739744QuadLock™ Fixation System 9mmNA2026-01-14
08437019739751QuadLock™ Fixation System 10mmNA2026-01-14
08437019739768QuadLock™ Fixation System 11mmNA2026-01-14
08437019739430WasherCap™ Countersink 11 mm212026-03-30
08437019739447WasherCap™ Inserter 11mm212026-03-30
08437019739454WasherCap™ Countersink Positioner 11mm212026-03-30
08437019739461Inserter Coupling Screw 11mm212026-03-30
28437019739748QuadLock™ Fixation System 9mmNA2026-01-14
28437019739755QuadLock™ Fixation System 10mmNA2026-01-14
28437019739762QuadLock™ Fixation System 11mmNA2026-01-14
08437019739867WasherCap™ Fixation System 11mm212025-03-10
28437019739861WasherCap™ Fixation System 11mm212025-03-10
08437019739898WasherCap Mini Fixation system 3.5mm452025-02-25
08437019739904WasherCap Mini Fixation system 4.5mm452025-02-25
28437019739892WasherCap Mini Fixation system 3.5mm452025-02-25
28437019739908WasherCap Mini Fixation system 4.5mm452025-02-25
08437019739485WasherCap™ Inserter 7mm & 8mm212023-06-01
08437019739669WasherCap™ Countersink Positioner 7mm212023-06-01
08437019739676WasherCap™ Countersink Positioner 8mm212023-06-01
08437019739683WasherCap™ Countersink Positioner 9mm212023-06-01

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Primary DI, Brand, Company table
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08698940971454SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
G4533312BT0PEAK MEDICALPeak Medical Distribution Inc.LXH2026-06-03
07613327648355PANGEAStryker GmbHLXH2026-06-02
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